RU2007100200A - Твердые оральные дозируемые формы на основе вальсартана - Google Patents
Твердые оральные дозируемые формы на основе вальсартана Download PDFInfo
- Publication number
- RU2007100200A RU2007100200A RU2007100200/15A RU2007100200A RU2007100200A RU 2007100200 A RU2007100200 A RU 2007100200A RU 2007100200/15 A RU2007100200/15 A RU 2007100200/15A RU 2007100200 A RU2007100200 A RU 2007100200A RU 2007100200 A RU2007100200 A RU 2007100200A
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- RU
- Russia
- Prior art keywords
- oral dosage
- pharmaceutically acceptable
- solid oral
- dosage form
- valsartan
- Prior art date
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- 239000006186 oral dosage form Substances 0.000 title claims 17
- 239000007787 solid Substances 0.000 title claims 15
- 239000004072 C09CA03 - Valsartan Substances 0.000 title claims 9
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 title claims 9
- 229960004699 valsartan Drugs 0.000 title claims 9
- 239000013543 active substance Substances 0.000 claims 8
- 150000003839 salts Chemical class 0.000 claims 8
- 239000000654 additive Substances 0.000 claims 7
- 239000008187 granular material Substances 0.000 claims 6
- 238000000034 method Methods 0.000 claims 5
- 239000007891 compressed tablet Substances 0.000 claims 4
- JZUFKLXOESDKRF-UHFFFAOYSA-N Chlorothiazide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC2=C1NCNS2(=O)=O JZUFKLXOESDKRF-UHFFFAOYSA-N 0.000 claims 3
- 229960002003 hydrochlorothiazide Drugs 0.000 claims 3
- 239000000203 mixture Substances 0.000 claims 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 3
- 230000000996 additive effect Effects 0.000 claims 2
- 230000006835 compression Effects 0.000 claims 2
- 238000007906 compression Methods 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 239000002245 particle Substances 0.000 claims 2
- 238000003825 pressing Methods 0.000 claims 2
- 239000003826 tablet Substances 0.000 claims 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 238000005056 compaction Methods 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 238000009490 roller compaction Methods 0.000 claims 1
- 238000007873 sieving Methods 0.000 claims 1
- 239000007909 solid dosage form Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/54—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one sulfur as the ring hetero atoms, e.g. sulthiame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/12—Drugs for disorders of the urinary system of the kidneys
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P21/00—Drugs for disorders of the muscular or neuromuscular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/04—Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/14—Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers
Claims (19)
1. Твердая оральная дозируемая форма, включающая
а) действующее вещество, содержащее эффективное количество вальсартана или его фармацевтически приемлемой соли и эффективное количество гидрохлортиазида (ГХТА), и б) фармацевтически приемлемые добавки, пригодные для изготовления твердых оральных дозируемых форм прессованием.
2. Твердая оральная дозируемая форма по п.1, включающая спрессованную оральную дозируемую форму, предпочтительно спрессованную методом сухого прессования оральную дозируемую форму.
3. Твердая оральная дозируемая форма по п.1 или 2, где включающая вальсартан или его фармацевтически приемлемую соль в количестве более чем 35 мас.%, предпочтительно в количестве от 45 до 65 мас.% на общий вес твердой оральной дозируемой формы.
4. Твердая оральная дозируемая форма по любому из предыдущих пунктов, включающая стандартную дозу вальсартана или его фармацевтически приемлемой соли, составляющую приблизительно от 10 до 250 мг, и стандартную дозу ГХТА, составляющую приблизительно от 6 до 60 мг.
5. Твердая оральная дозируемая форма по любому из предыдущих пунктов в форме таблетки.
6. Таблетка, включающая а) действующее вещество, содержащее эффективное количество вальсартана или его фармацевтически приемлемой соли, и б) в качестве фармацевтически приемлемой добавки микрокристаллическую целлюлозу в количестве от 15 до 25 мас.%.
7. Спрессованная таблетка по п.6, где действующее вещество присутствует в количестве более чем 35 мас.%, предпочтительно в количестве от 45 до 65 мас.% на общий вес композиции.
8. Спрессованная таблетка по п.6 или 7, где действующее вещество полностью состоит из вальсартана или его фармацевтически приемлемой соли в дозе, составляющей приблизительно от 10 до 250 мг.
9. Спрессованная таблетка по любому из пп.6-8, которая включает сшитый поливинилпирролидон (ПВП) в качестве фармацевтически приемлемой добавки.
10. Спрессованная таблетка по п.9, где количество сшитого ПВП составляет от 2 до 20 мас.%.
11. Твердая оральная дозируемая форма, полученная сухим прессованием, содержащая а) действующее вещество, содержащее эффективное количество вальсартана или его фармацевтически приемлемой соли, и б) фармацевтически приемлемые добавки, пригодные для приготовления твердых оральных дозируемых форм прессованием.
12. Твердая оральная дозируемая форма по п.11, где действующее вещество полностью состоит из вальсартана или его фармацевтически приемлемой соли в дозе составляющей приблизительно от 10 до 250 мг.
13. Способ изготовления твердой оральной дозируемой формы, включающей
а) действующее вещество, включающее эффективное количество вальсартана или его фармацевтически приемлемой соли, и
б) фармацевтически приемлемые добавки, пригодные для приготовления твердой оральной дозируемой формы прессованием, включающий следующие этапы:
I) действующее вещество и фармацевтически приемлемые добавки измельчают,
II) смесь измельченного действующего вещества и добавок прессуют с получением копримата, причем прессование для получения копримата требует уплотнения сухой смеси измельченных компонентов,
III) копримат превращают в гранулят и
IV) гранулят прессуют с получением твердой оральной дозируемой формы.
14. Способ по п.13, где размер частиц полученного гранулята варьируется в пределах от 9 до 340 мкм.
15. Способ по п.13 или 14, где гранулят вначале выходит из валкового уплотнителя после просеивания или размалывания и содержит частицы как слишком малого, так и слишком большого размеров для формирования твердых дозируемых форм.
16. Способ по любому из пп.13-15, где гранулят изготавливают под давлением от 25 до 65 кН.
17. Коприматы, полученные путем валкового уплотнения или штамповки по пп.13-16.
18. Гранулят, полученный способом по любому из пп.13-16.
19. Твердая оральная дозируемая форма, изготовленная способом по любому из пп.13-16.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| GBGB9613470.5A GB9613470D0 (en) | 1996-06-27 | 1996-06-27 | Small solid oral dosage form |
| GB9613470.5 | 1996-06-27 |
Related Parent Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU99101056/14A Division RU2203054C2 (ru) | 1996-06-27 | 1997-06-18 | Твердые оральные дозирумые формы на основе вальсартана |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2009115778/15A Division RU2009115778A (ru) | 1996-06-27 | 2009-04-27 | Твердые оральные дозируемые формы на основе вальсартана |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2007100200A true RU2007100200A (ru) | 2008-07-20 |
| RU2453306C2 RU2453306C2 (ru) | 2012-06-20 |
Family
ID=10795969
Family Applications (5)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU99101056/14A RU2203054C2 (ru) | 1996-06-27 | 1997-06-18 | Твердые оральные дозирумые формы на основе вальсартана |
| RU99101056/63D RU2294743C2 (ru) | 1996-06-27 | 1997-06-18 | Твердые оральные дозирумые формы на основе вальсартана |
| RU2007100200/15A RU2453306C2 (ru) | 1996-06-27 | 2007-01-10 | Твердые оральные дозируемые формы на основе вальсартана |
| RU2009115778/15A RU2009115778A (ru) | 1996-06-27 | 2009-04-27 | Твердые оральные дозируемые формы на основе вальсартана |
| RU2013113610/15A RU2013113610A (ru) | 1996-06-27 | 2013-03-26 | Твердые оральные дозируемые формы на основе вальсартана |
Family Applications Before (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU99101056/14A RU2203054C2 (ru) | 1996-06-27 | 1997-06-18 | Твердые оральные дозирумые формы на основе вальсартана |
| RU99101056/63D RU2294743C2 (ru) | 1996-06-27 | 1997-06-18 | Твердые оральные дозирумые формы на основе вальсартана |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2009115778/15A RU2009115778A (ru) | 1996-06-27 | 2009-04-27 | Твердые оральные дозируемые формы на основе вальсартана |
| RU2013113610/15A RU2013113610A (ru) | 1996-06-27 | 2013-03-26 | Твердые оральные дозируемые формы на основе вальсартана |
Country Status (33)
| Country | Link |
|---|---|
| US (3) | US6294197B1 (ru) |
| EP (7) | EP1776953A1 (ru) |
| JP (5) | JP2000506540A (ru) |
| KR (6) | KR20060079260A (ru) |
| CN (3) | CN1133427C (ru) |
| AR (2) | AR008618A1 (ru) |
| AT (3) | ATE276750T1 (ru) |
| BR (1) | BR9709956A (ru) |
| CA (2) | CA2259148C (ru) |
| CO (1) | CO4870755A1 (ru) |
| CY (1) | CY2553B1 (ru) |
| CZ (1) | CZ296850B6 (ru) |
| DE (3) | DE69739642D1 (ru) |
| DK (3) | DK0914119T3 (ru) |
| ES (3) | ES2335683T3 (ru) |
| GB (1) | GB9613470D0 (ru) |
| HK (2) | HK1019858A1 (ru) |
| HU (1) | HU229134B1 (ru) |
| ID (1) | ID17553A (ru) |
| IL (2) | IL127564A0 (ru) |
| MY (3) | MY146868A (ru) |
| NO (2) | NO317181B1 (ru) |
| NZ (2) | NZ333385A (ru) |
| PE (1) | PE87498A1 (ru) |
| PL (2) | PL188271B1 (ru) |
| PT (3) | PT1767206E (ru) |
| RU (5) | RU2203054C2 (ru) |
| SI (2) | SI1410797T1 (ru) |
| SK (1) | SK285902B6 (ru) |
| TR (1) | TR199802698T2 (ru) |
| TW (1) | TW473394B (ru) |
| WO (1) | WO1997049394A2 (ru) |
| ZA (1) | ZA975673B (ru) |
Families Citing this family (91)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB9613470D0 (en) * | 1996-06-27 | 1996-08-28 | Ciba Geigy Ag | Small solid oral dosage form |
| US20030045561A1 (en) * | 2001-02-06 | 2003-03-06 | Smithkline Beecham Corporation | Method of treating isolated systolic hypertension |
| CN1291888A (zh) * | 1998-03-04 | 2001-04-18 | 武田药品工业株式会社 | Aⅱ拮抗剂的缓释制剂、其制备和用途 |
| DK1736144T3 (en) | 1998-05-18 | 2015-12-07 | Takeda Pharmaceutical | Orally disintegrating tablets. |
| RU2450813C2 (ru) * | 1998-07-10 | 2012-05-20 | Новартис Аг | Гипотензивная комбинация валсартана и блокатора кальциевых каналов |
| SI1588706T1 (sl) | 1998-12-23 | 2012-01-31 | Novartis Ag | Tableta valsartana |
| CN101011390A (zh) | 1999-01-26 | 2007-08-08 | 诺瓦提斯公司 | 血管紧张素ⅱ受体拮抗剂在治疗急性心肌梗塞中的应用 |
| AU766453C (en) * | 1999-01-26 | 2004-11-25 | Novartis Ag | Use of angiotensin II receptor antagonists for treating acute myocardial infarction |
| AU783855B2 (en) * | 1999-08-24 | 2005-12-15 | Medicure International Inc. | Compositions for the treatment of cardiovascular diseases containing pyridoxal compounds and cardiovascular compounds |
| DE10014416B4 (de) * | 2000-03-24 | 2009-02-19 | 3M Espe Ag | Verwendung feinkörniger Pulver bzw. Pulvergemische zur Herstellung eines Mittels für supragingivales Pulverstrahlen |
| CA2311734C (en) * | 2000-04-12 | 2011-03-08 | Bristol-Myers Squibb Company | Flash-melt oral dosage formulation |
| US20020132839A1 (en) * | 2000-06-22 | 2002-09-19 | Ganter Sabina Maria | Tablet formulations comprising valsartan |
| HUP0301390A3 (en) * | 2000-06-22 | 2005-04-28 | Novartis Ag | Oral pharmaceutical composition containing valsartan |
| AU2005200815B2 (en) * | 2000-06-22 | 2008-01-17 | Novartis Ag | Solid valsartan pharmaceutical compositions |
| CN1216873C (zh) | 2000-07-19 | 2005-08-31 | 诺瓦提斯公司 | 缬沙坦的盐 |
| US20060089389A1 (en) | 2000-08-22 | 2006-04-27 | Malcolm Allison | Combination |
| PE20020617A1 (es) * | 2000-08-22 | 2002-08-05 | Novartis Ag | Composicion que comprende un antagonista del receptor at1 y un potenciador de la secrecion de insulina o un sensibilizante a la insulina |
| US8168616B1 (en) | 2000-11-17 | 2012-05-01 | Novartis Ag | Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension |
| US20040219208A1 (en) * | 2001-08-03 | 2004-11-04 | Ryu Kawamura | Sustained-release medicines |
| GB0209265D0 (en) * | 2002-04-23 | 2002-06-05 | Novartis Ag | Organic compounds |
| EG24716A (en) | 2002-05-17 | 2010-06-07 | Novartis Ag | Combination of organic compounds |
| DE10230272A1 (de) * | 2002-07-05 | 2004-01-22 | Solvay Pharmaceuticals Gmbh | AT1-Rezeptorantagonisten zur Prävention von Folgeschlaganfällen |
| EP1382334A1 (en) * | 2002-07-11 | 2004-01-21 | Université de Picardie Jules Verne | Use of angiotensin II AT1-receptor blockers (ARB), alone or combined with thiazide or angiotensin II for the treatment of stroke |
| US7199144B2 (en) * | 2003-04-21 | 2007-04-03 | Teva Pharmaceuticals Industries, Ltd. | Process for the preparation of valsartan and intermediates thereof |
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